Vascular Biogenics Ltd (VBLT)

[INFINITI]

Already did let’s gooo$$$

[midastouch017]

Better average down, the
game is not over yet!

[INFINITI]

Cmon let’s push this back up $$$$

[dtgsanjose]

I would guess that the $5 target was announced before today's news of the failure to meet the milestones on the recently completed trial. I sold most of my shares today and can buy back later if something promising emerges, but I am not holding my breath.

[INFINITI]

Vascular Biogenics (VBLT) Receives a Hold from JonesTrading

Source: TipRanks
In a report released today, Soumit Roy from JonesTrading maintained a Hold rating on Vascular Biogenics (VBLT – Research Report). The company's shares closed last Tuesday at $2.05. According to TipRanks.com, Roy is a 4-star analyst with an average return of 5.5% and a 32.0% success rate. Roy covers the Healthcare sector, focusing on stocks such as Deciphera Pharmaceuticals, Actinium Pharmaceuticals, and Adaptimmune Therapeutics. Currently, the analyst consensus on Vascular Biogenics is a Hold with an average price target of $5.00, which is a 143.9% upside from current levels. In a report released today, Oppenheimer also downgraded the stock to Hold.
https://www.tipranks.com/news/blurbs/vascular-biogenics-vblt-receives-a-hold-from-jonestrading?utm_source=advfn.com&utm_medium=referral

[INFINITI]

There’s alot of traders bought well over $2 they are not going g to sell this low

[declaes]

$5 before today's news... would be nice to see $1 again here. Still 100% but be careful. Gl

[INFINITI]

Got in couldn’t resist the cheapies analyst target $5

[INFINITI]

Only over if you sell

[midastouch017]

VBLT - Game Over!

https://finance.yahoo.com/news/vbl-therapeutics-announces-top-line-200100153.html

[midastouch017]

VBL Therapeutics Selected for €17.5 Million of Funding from Horizon Europe EIC Accelerator Program

https://finance.yahoo.com/news/vbl-therapeutics-selected-17-5-123000594.html

VBL is among only 9% of companies across industries selected by the EIC Accelerator

Funds to be used for clinical development, CMC, and pre-commercialization activities for ofra-vec (VB-111)

TEL AVIV, Israel and NEW YORK, Dec. 20, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, today announced that it has been selected for €17.5 million of blended funding by the European Innovation Council (EIC) Accelerator. The funding is comprised of a €2.5 million grant and an additional €15 million direct equity investment by the EIC.

The EIC Accelerator is a prestigious competitive program of the European Commission, which offers grants combined with equity investments through the EIC Fund. In addition to financial support, all projects benefit from a range of Business Acceleration Services that provide access to leading expertise, corporates, investors and ecosystem actors.

“We are honored to have been selected in this prestigious and competitive program, where only nine percent of companies got funded, with only a small fraction of those in biopharma,” said Dror Harats, M.D., Chief Executive Officer of VBL. “In selecting us for this grant and investment, we believe the EIC recognized the value proposition that ofra-vec (VB-111) potentially offers to patients and the high unmet need that exists in ovarian cancer. Ofra-vec offers a novel targeted gene based approach to the way cancer is treated, and if approved, can potentially address some of the key challenges in treating ovarian cancer and establish a new standard of care. We are grateful for the EIC’s support and alignment in our collective mission to improve the lives of patients with cancer.”

The EIC Accelerator’s support comes at a pivotal time for VBL. VBL is nearing the completion of enrollment in the ongoing Phase 3 OVAL registration-enabling clinical trial of ofra-vec (VB-111) in ovarian cancer, with the top-line progression free survival (PFS) co-primary endpoint data readout expected in the second half of 2022. The funds from the EIC will be used to support clinical development, Chemistry Manufacturing and Controls (CMC), and pre-commercialization activities.

For more information about the EIC Accelerator, refer to https://eic.ec.europa.eu/eic-funding-opportunities/eic-accelerator_en.

About VBL Therapeutics

Vascular Biogenics Ltd., operating as VBL Therapeutics (VBL), is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for difficult-to-treat malignant solid tumors and immune or inflammatory indications. VBL’s novel VTS™ gene-based platform and antibody-based monocyte targeting technology enable the creation of a pipeline of programs that harness the body’s innate biological processes to provide unique solutions for significant unmet medical needs. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111; 'ofra-vec'), is an investigational, first-in-class, targeted anti-cancer gene-based agent in development to treat a wide range of solid tumors. VB-111 is currently being studied in a Phase 3 registration-enabling clinical trial (NCT03398655) for platinum-resistant ovarian cancer. To learn more about VBL, please visit vblrx.com or follow the company on LinkedIn, Twitter, YouTube or Facebook.

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Vascular Biogenics Ltd. (VBLT) CEO Dror Harats on Q3 2021 Results - Earnings Call Transcript

Nov. 15, 2021 2:08 PM ETVascular Biogenics Ltd. (VBLT)
Vascular Biogenics Ltd. (NASDAQ:VBLT) Q3 2021 Earnings Conference Call November 15, 2021 8:30 AM ET

Company Participants

Dror Harats - Chief Executive Officer

Sam Backenroth - Chief Financial Officer

Conference Call Participants

Kevin DeGeeter - Oppenheimer

Swayampakula Ramakanth - H.C. Wainwright

Jonathan Aschoff - ROTH Capital Partners

Jonathan Kreizman - Valore Research

Operator

Good morning and welcome to VBL Therapeutics Third Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode and please note that this conference is being recorded. A question and answer session will follow the formal presentation. [Operator Instructions]

I would now turn the conference over to our host from VBL team. Please go ahead.

Unidentified Company Representative

Thank you. Good morning, everyone, and thank you for joining VBL Therapeutics third quarter 2021 financial results and corporate update call. Joining me on the call is Professor Dror Harats, Chief Executive Officer; and Sam Backenroth, Chief Financial Officer. The press release of the company's financial results was issued earlier this morning and is available on the Investor Relations page of the VBL's website at ir.vblrx.com.

Before turning the call over to Dror and Sam, I would like to remind everyone that during this conference call, forward-looking statements made by management are intended to fall within the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934 as amended. As set forth in our press release, forward-looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the SEC, which include, among other things, our annual report on Form 20-F. These filings are available from the SEC or on our website.

Any forward-looking statements made on today's conference call speak only as of today's date, Monday, November 15, 2021, and the company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today's date. As a reminder, this call is being recorded and will be available for audio rebroadcast on the company's website. There will be a Q&A session following the company's prepared remarks.

With that, I'd like to turn the call over to Professor Harats. Dror please go ahead.

Dror Harats

Thank you, [Eric] and good morning, everyone. Joining me on today's call is Sam Backenroth, our new Chief Financial Officer, who will discuss the third quarter financial results for 2021.

We continue to execute on our development programs and strategic objectives and look forward to 2022 which we believe is going to be transformational year for VBL. We expect to have data from multiple VB-111 clinical trials in high value indications including the progression free survival co-primary endpoint from the phase III overall study in ovarian cancer. We also anticipate beginning first in human studies evaluating VB-601, our monocytes targeting antibody for the treatment of chronic immune inflammatory diseases.

Our overall clinical trial registration enabling phase III study of VB-111 in ovarian cancer has now enrolled over 85% of the targeted study patient population and we expect to complete enrollment in the first quarter of 2022. Also, in the first quarter of next year, we expect to have another DSMC review, which will include a dataset of almost 100%, if not a 100% of the total study population. The next milestone in the OVAL trial we are looking forward to is a readout of the progression free survival co-primary endpoint in the second half of 2022.

This is particularly important and successfully meeting the PFS endpoint has the potential to enable us to submit BLA one year ahead of plan compared to our original projections, which were based on the readout of the overall survival primary endpoint, which remain anticipated in 2023.

In addition to the readout in ovarian cancer in 2022 we also expect preliminary data from the investigator sponsored clinical trial of VB-111 in colorectal cancer in the first half of 2022 and from the recurrent GBM trial in the second half of 2022. We believe that VB-111 based on its dual mechanism of action, targeting tumor vasculature and immune recruitment has the potential to change the standard of care in multiple solid tumor indications.

As for our pipeline, we continue to advance our monocytes targeting program and expect to initiate a first in human study for our lead candidate VB-601 in 2022. We believe that VB-601 add a new and differentiated approach in the landscape of anti-inflammatory agents by specifically targeting monocytes which are crucial for the development of chronic immune inflammatory diseases. Based on our promising preclinical data, VB-601 may have applicability for a range of high value immune inflammatory indications.

To prepare the company for the continued growth and the commercialization of VB-111 we’ve recently strengthened our management and board and opened a U.S. office in addition to the appointment of Sam Backenroth as CFO. We also added Mike Rice and Alison Finger to the board. Mike has many years of capital markets and IR experience with particular expertise in helping emerging biopharma companies, attract a high quality investors. Alison bring nearly three decades of leadership experience in biotech and pharma. She was previously Chief Commercial Officer at Bluebird Bio, where she built the commercial infrastructure in Europe and the U.S. in advance of Bluebirds first gene and cell therapy product launches.

VBL is well capitalized with expected cash runway into the fourth quarter of 2023 significantly beyond the PFS readout and potential BLA filing. And we are excited to be building momentum as we head into 2022 a year with a number of potential catalysts and multiple opportunities to create value.

At this point, I would like to introduce Sam Backenroth our Chief Financial Officer to the audience. Sam has proven track record in corporate, finance, strategy, operations, and business development. And I'm confident that his leadership and strong investor in banking relationships will help VBL as we enter a new era of innovation and growth.

With that, I will hand over to Sam to discuss the third quarter 21 financial results. Sam, please go ahead.

Sam Backenroth

Thank you Dror and good morning everyone. First of all, I would like to say how thrilled I am to be working with VBL's management team and board of directors to capitalize on our tremendous potential to bring novel therapies to people with cancer and immune inflammatory disorders. What drew me to VBL was the company's cutting edge science and deep understanding of biology coupled with an experienced and driven team with the ability to develop highly differentiated therapeutics.

I'm especially impressed by the corporate culture at VBL and commitment of the entire team to help cancer patients in need and improve the standard of care. I'm excited to be leading the build-up of VBL's U.S. operations, as we head towards significant inflection points in 2022 and begin preparing for a potential commercial launch of VB-111. My appointment is consistent with the company's plan to raise awareness with investors and I look forward to meeting some of you in person in the coming months.

Now on to the third quarter financial results. As of September 30 2021 we had cash, cash equivalents, short term bank deposits and restricted bank deposits totaling $50.8 million. After the quarter ended, we received an additional $9.6 million in proceeds from warrant exercises. We expect that our cash and cash equivalents and short term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023.

Revenues for the third quarter were $0.2 million as compared to $0.2 million for the comparable period in 2020. R&D expenses net was $5 million for the third quarter as compared to $4.6 million in the same period of 2020. For general and administrative expense it was $1.6 million for the third quarter as compared to $1.3 million in the same period for 2020. And finally, comprehensive loss for the third quarter was $6.5 million or $0.09 per ordinary share compared to $5.8 million or $0.12 per basic share in the comparable period in 2020.

With that I would like to return the call back to the operator for the question and answer portion of this morning's call. Thank you.

Question-and-Answer Session

Operator

Thank you. We will now begin the question and answer session. [Operator Instructions] Our first question comes from Kevin DeGeeter of Oppenheimer. Please go ahead.

Kevin DeGeeter

Hey, thanks for the update. I guess a few things from us, Dror congratulations on the progress with overall enrollment. I guess with a positive PFS readout should we think about the timeline of clinical data is being the rate limiting step to a potential regulatory filing or there additional CMC investments that we should also think about as being relevant to, we think about potential timeline for future BLA filing?

Dror Harats

So thank you, Kevin. That's a very good question. And as you know we have our own facility, commercial grade facility here in Israel and I know that many times in gene and cell therapy, the issue of production is a major issue, but we were actually preparing it ahead of time. And as you know the CMC portion of the agency was already reviewing our release test laboratory and actually approved it and also all the batches that were used in the clinical trial and are used in the clinical trial. So I believe that we are actually doing quite well with a CMC and having a good result on the PFS, we will be able to actually be in a position to work on and submitted BLA including the CMC.

Kevin DeGeeter

Great. And then with regard to, I guess continued patient access to VB-111 ovarian cancer following completion of enrollment early next year, are there any plans for expanded access or compassionate use program that may be able to gather data that could be helpful from a pre-commercialization perspective?

Dror Harats

Okay, so that's always a debate that the company should take because that's before you have a proof of concept that the drug is working, although we had a very good phase II and also the interim analysis give us a good hint that VB-111 is actually working in ovarian but you need the full proof that's on one hand. On the other hand you know that we never want to actually patient close to a VB-111 if they were on the control arm because the second primary endpoint that we are looking for is overall survival.

So I believe that from the time that we are going to be fully recruited, until the time that we will be able actually been able to talk about the top line results on PFS are not going to be such a long time and because of that, the plan is that if we will be in with a positive top line result as we all hoped and expected, then of course, we will start an access Program. Although I have to remind everybody that because the study is going also for overall survival, we might be in a position that the PFS is actually working very well and we are submitting BLA but the study will go on for the overall survival.

So we will actually look at it in a very careful way. But we are making enough drug right now to be able to actually use it as an access program and compassionate to patient because as you all know, this is a deadly disease and VB-111 might be a new way to actually change the standard of care for these patients and bring hope to this patient.

Kevin DeGeeter

Well, congratulations on your progress and thank you for taking our questions.

Dror Harats

Thank you very much Kevin.

Operator

Our next question comes from Swayampakula Ramakanth of H.C. Wainwright. Please go ahead.

Swayampakula Ramakanth

Thank you. Good afternoon, folks and welcome aboard Sam. So a couple of quick questions from me on the DSM review that is expected to take place in the first quarter as you said you would potentially have data from almost all of the patients in the trial. So at that point, what sort of indication are you going to get and are you going to let investors know from that review?

Dror Harats

So RK I'll take this question. When the DSMC is looking at the full data, we are seeing only the blended total population data. So we don't know who is who. But we do see the results on each of the endpoint, but we are not talking about it. We're very careful about it. On the other hand, the DSMC is actually seeing the full data including all the primary endpoint where they can compare and get a data on each separate group. But it's, of course, not the clean data. It wasn't the data after all the queries. So although it's going to be 100%, they will be patient and wait a little bit, until we clean the data and get top line results.

So my guess is that they will have the chance to tell us that we got the green light, and we should go forward and they of course might indicate to us if we should expedite and get things cleaned up. But they'll never stop a trial without looking at clean up data.

Sam Backenroth

Yes and just to add to that, I think just importantly from a disclosure perspective what you'd likely to see as an investor, or somebody looking at the story, would be something very similar to what we've disclosed in the past, the DSMC has their meeting, and then we give the very high level results and that, whatever their recommendation was with regard to moving forward.

Swayampakula Ramakanth

Thank you. And then, as it stated next year the Europe data on VB-111. So thinking about colorectal cancer and GBM, I understand this are being run by independent investigators. And it's up to them as to what sort of data but in general, what should be the expectations from these groups on both the indications?

Dror Harats

So as you know RK, when it is a NCI or investigator initiated trial, we depend on the NCI and all the doctors who run the trial. So it's more difficult to ask to say exactly the date or thing that we expect. Having saying that I have to say a couple of things. First, in the colorectal, as I'm saying always on these calls and I'm saying it whenever we meet with investors, we're looking to see if we can bring the immune system into their colon because the colon has a different immune system.

And that's the goal of the trial in our point and we will know that hopefully in the first half of ‘22 but I can't say exactly when. In regarding to the GBM, the trial is a double blind, placebo control, just as a reminder, and it has three groups. The group A is actually getting VB-111 as a new adjuvant before a second surgery.

All patients are recurrent GBM. All patients already failed surgery, radiation and chemotherapy. So they have quite a great prognosis. But they're going to second operation. The first group will get a VB-111 as new adjuvant then later on after surgery as adjuvant. The second group is getting a placebo as a new adjuvant and then VB-111. And the third group is getting placebo as new adjuvant and then the standard of care. So the idea is in this trial is that we are getting the tissue of the tumor and a third of the patient we get VB-111 before surgery.

So we will be able to know if VB-111 indeed bring immune cell and change of genetic of GBM as we think it should do and as we have evidence in animal models and other indication in human being but never in the brain of that will be an opportunity to see that. From that on the trial is actually not a blinded because who is on standard of care and who is getting VB-111. And we're looking at six months, PFS and overall survival. When we will have enough patient and the investigator will think that that's a good time to summarize the data. We will come to the market of course with these results usually with some a presentation at the clinical conference.

Swayampakula Ramakanth

Okay. So do you think that data if everything goes right, is that enough to go to the FDA or do you need to do another trial to file for VB-111 and GBM?

Dror Harats

Okay. The GBM trial was planned, I believe in a good way it's not a big trial, but it's a randomized controlled trial. And even when we got the results of the phase II trial that that was successful, the issue that the agency had to give us accelerate a registration was because it wasn't a controlled trial.

So even in a small control trial if you can show evidence of efficacy in this deadly disease, where nothing else working, we will apply for accelerate approval for GBM, if we will get it or not, we will have to discuss it with the agency. And of course, it all depends on the strength of the data that we will get here.

Swayampakula Ramakanth

Okay. So one last question from me. I know, oncology is one of the major focuses for VBL. With the start of the VB-601 study next year, how far would you take this molecule in development before seeking a partner for further development and commercialization?

Sam Backenroth

Yes. So that's a great question. And it's Sam here. I think that really remains to be seen. And we're designing a first in human clinical trial that we think is going to get us both safety as well as potential proof of concept in the ability to target monocytes, which as you know are one of the three cell types that are implicated in inflammation, yet we don't really have therapeutics that can go ahead and address the monocytes specifically.

So I think that that would probably be the right time once we have that proof of concept to start thinking about potentially bringing on a partner that will allow us to go after some much larger applications whether that's rheumatoid arthritis, whether that's ulcer colitis, Crohn's or other diseases like MS that will remain to be seen, but certainly we would believe at that point that it would make sense for us to go at it with a good strong partner.

Swayampakula Ramakanth

Thank you, Sam. Thanks Dror. Talk to you soon.

Dror Harats

Thank you, RK.

Operator

Our next question comes from Jonathan Aschoff of ROTH Capital Partners. Please go ahead.

Jonathan Aschoff

Thanks. Good morning, guys and welcome aboard, Sam. Can you be more specific about what you're currently doing to prepare for potentially successful OVAL at the PFS readout, such that you'd be in an optimal position to swiftly file for approval and commercialize VB-111 saying something that would perhaps help us judge your PFS optimism?

Sam Backenroth

Yes. So Jonathan, that's a great question. And we're really full steam ahead on all fronts right now as Dror mentioned before, we're doing the CMC preparatory work in order to enable us to be able to file BLA as soon as possible once we have the PFS results and we're investing in that right now. In addition to that, we are in the process of conducting a search for a Chief Commercial Officer to do all the pre-commercialization work, market access, pricing, reimbursement and everything that we really need to do to get ahead of things to be ready for hopefully a positive PFS readout.

And then ultimately the launch of a drug. So we are doing everything that we can in order to accelerate and prepare ourselves for a positive result that will allow us to go ahead and file this off of a PFS.

Jonathan Aschoff

Okay, thank you very much Sam.

Sam Backenroth

Thanks, Jonathan.

Operator

[Operator Instructions] Our next question comes from Jonathan Kreizman of Valore Research. Please go ahead.

Jonathan Kreizman

Hi, everyone. Hi, Sam. Congrats for assuming the role and wishing you all the best in this exciting phase of the VBL's lifetime, also want to congratulate Amos for the long year leadership and involvement in the long journey to develop VBL-111 and the rest of the programs. So congrats to both of you. Question for Dror. I noticed some of the timelines for several programs have moved a little further. Maybe if you could elaborate on the reasons for some of these delays for instance, 601 entering the clinic in the second half of ‘22 and colorectal cancer study which you initially expected to read out in the end of ‘21.

Dror Harats

I think it's quite obvious in what we are facing right now in the world with the pandemic. There are issues with a chain of commerce and there are issues with having a place to actually make the antibody because we know that a lot of effort was a actually shifted towards a producing vaccines for the COVID-19. And actually, we are basically ready for a submitting an IND or starting the clinical trial except for the concluding of the production of the GMP manufacturing of 601. And that was a bit delayed because of the pandemic. And I think that that's the only reason.

So nothing is changing the programming, it's just the change that we are having now in the landscape of a production in the world. And I'm glad to say that right now we are on track. And that's why I could mention that we are planning to have first in [men] already in 2022.

As far as other clinical trials as I was saying before, the colorectal is actually a NCI study. And the GBM is an investigator initiated study and you always depend on the investigators in this. But I don't think it's a bad signal when a clinical trial where you look for a clinical events in oncology is taking a longer period of time and we're depends on having enough patient, that we'll have enough biopsies in the colorectal trial before we can come with any results. And of course, it's not us that going to summarize these result and when we will get it from the NCI we will definitely share it with the market.

Jonathan Kreizman

Okay, great. Question for Sam. So I'd appreciate to hear some of your thoughts as you're working through the learning curve of gaining familiarity with a company and besides that, if you could share any points or particular observations on which you intend to act upon in the short and medium term. Thanks.

Sam Backenroth

Yes, no, great question. And I think, my learning curve has been relatively short here, because I've spent the last couple years in genetic medicines. So that my understanding of the technology, or at least the basic elementary understanding is there. And now that I've been here for about six weeks, certainly continuing to learn and now I'm already getting out there and starting to talk to investors about the story and you're looking both at the VB-111 as well as the 601 program and its application across multiple different inflammatory disorders.

I will say that working with the team has been fantastic so far. We've really been able to come together and further the goals of the company to really accelerate drug development and bring these very important cutting edge novel therapeutics to patients as soon as possible. And I think we continue to execute on that plan. And we've really set up 2022 be an incredibly exciting year for the company on both programs, multiple data readouts on the clinical side, and then entering the clinic and the second program. I think we're really primed for, a great 2022 here.

Jonathan Kreizman

Okay, great. Thanks and good luck again.

Sam Backenroth

Thank you.

Operator

This concludes the question and answer session. I would like to turn the conference back over to the company for any closing remarks.

Dror Harats

So thank you everybody for joining us on today call and have a wonderful day. Thank you very much.

Operator

This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.

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VBL Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update

https://finance.yahoo.com/news/vbl-therapeutics-reports-third-quarter-123000354.html

Conference Call and Webcast at 8:30 a.m. ET Today

Data from multiple VB-111 clinical trials expected in 2022, including the progression free survival (PFS) co-primary endpoint from the Phase 3 OVAL study expected in the second half of 2022

More than 85% of the planned 400 patients in the OVAL Phase 3 study evaluating VB-111 in platinum resistant ovarian cancer have been enrolled; remains on track to complete enrollment in the first quarter of 2022

VB-601, a monoclonal antibody targeting monocytes for prevalent and chronic inflammatory disorders, expected to enter the clinic in the second half of 2022

TEL AVIV, Israel and NEW YORK, Nov. 15, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, today announced financial results for the third quarter ended September 30, 2021, and provided a corporate update.

“We continue to execute on our development and strategic objectives which we believe positions 2022 as a potentially transformational year for VBL,” said Dror Harats, M.D., Chief Executive Officer of VBL. “We look forward to completing the enrollment in the Phase 3 OVAL study in the first quarter of 2022 and the PFS co-primary endpoint top-line data readout in the second half of 2022. We also expect to initiate a first-in-human trial with VB-601, our monocyte targeting program, in the second half of 2022. With the recent strengthening of our management and board of directors, together with our newly established presence in the United States, we are taking important steps to prepare VBL for continued growth and the planned commercialization of VB-111.”

Third Quarter of 2021 and Recent Corporate Highlights

Development Programs

More than 85% of the planned 400 patients have been enrolled in the OVAL study, a global registration-enabling Phase 3 clinical trial evaluating VB-111 in platinum-resistant ovarian cancer.

The independent Data Safety Monitoring Committee (DSMC) conducted its fifth pre-planned data review of the OVAL study and provided clearance to proceed as planned with no changes to the protocol.

The Chemistry, Manufacturing, and Controls group of the U.S. Food and Drug Administration provided VBL clearance of VB-111 batches produced in its commercial-scale facility located in Modiin, Israel, for use in the Company’s clinical trials in the United States.

Enrollment continues in the VB-111 investigator-sponsored Phase 2 clinical trials in recurrent glioblastoma multiforme (rGBM) and metastatic colorectal cancer (mCRC) with preliminary data expected from the mCRC study in the first half of 2022 and the rGBM study in the second half of 2022.

IND-enabling toxicology studies are underway for VB-601, a monoclonal antibody targeting monocytes for prevalent and chronic inflammatory disorders, and VBL expects to initiate a first-in-human clinical trial for the program in the second half of 2022.

Corporate

Further strengthened the management team with the appointment of Sam Backenroth as chief financial officer. In connection with the appointment, VBL established U.S. operations in New York, as the company prepares for anticipated growth.

Enhanced the board of directors (Board) with the appointments of Alison Finger and Michael Rice, who bring significant commercialization and capital markets expertise to VBL. Also completed the planned chairman succession to Marc Kozin, who initially joined the Board as vice chairman in October 2020.

Financial Results for the Third Quarter of 2021

At September 30, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $50.8 million. After September 30, 2021, the company received a further $9.6 million in proceeds from warrant exercises. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures into the fourth quarter of 2023.

For the quarter ended September 30, 2021, VBL reported a net loss of $6.5 million, or ($0.09) per basic share, compared to a net loss of $5.8 million, or ($0.12) per basic share, in the comparable period in 2020.

Revenues for the quarter ended September 30, 2021, were $0.2 million, as compared to $0.2 million in the comparable period in 2020.

For the quarter ended September 30, 2021, total operating expenses were approximately $6.6 million, consisting of $5.0 million in research and development expenses, net, and $1.6 million in general and administrative expenses. This compares with total operating expenses of $5.9 million in the third quarter ended September 30, 2020, which was comprised of $4.6 million in research and development expenses, net, and $1.3 million in general and administrative expenses.

Conference Call and Webcast:

Monday, November 15 at 8:30 a.m. ET

Conference ID: 10017250

US: 855-327-6837

Israel Local: 1-809-458-327

International: 631-891-4304

Webcast: https://edge.media-server.com/mmc/p/3bwajjar

The live webcast will be available online and may be accessed from the “Events and Presentation” page of VBL’s website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

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VBL Therapeutics to Report Third Quarter Financial Results on November 15

https://finance.yahoo.com/news/vbl-therapeutics-report-third-quarter-130000155.html

TEL AVIV, Israel and NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT), a clinical stage company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, today announced that it will release third quarter financial results for the period ended September 30, 2021 on Monday, November 15 before market open. Professor Dror Harats, M.D, Chief Executive Officer, and Sam Backenroth, Chief Financial Officer, will host a conference call at 8:30am ET to discuss the results and provide a corporate update.

Conference Call:

Monday, November 15, 2021 at 8:30am ET

Conference ID: 10017250

US: 855-327-6837

Israel Local: 1-809-458-327

International: 631-891-4304

Webcast: https://edge.media-server.com/mmc/p/3bwajjar

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Form 6-K

As previously disclosed, on October 19, 2021, Vascular Biogenics Ltd. (the “Company”) convened its 2021 annual general meeting of shareholders (the “Meeting”) at 4.00 p.m. (Israel time) at the Company’s offices at 8 HaSatat St. Modi’in, Israel.

At the Meeting, following establishment of a quorum, the Company’s shareholders voted on six proposals, which are summarized below and described in more detail in the Company’s Notice of Annual General Meeting of Shareholders of Vascular Biogenics Ltd. that was attached as Exhibit 99.1 to a Report of Foreign Private Issuer on Form 6-K that we furnished to the Securities and Exchange Commission on September 2, 2021.

Proposal 1: To approve the nomination of Dr. Bennett M. Shapiro, Prof. Dror Harats, Ms. Ruth Alon, Dr. Shmuel (Muli) Ben Zvi, Dr. Ron Cohen, Mr. David Hastings and Mr. Marc Kozin to the Board, to serve until the next annual general meeting of shareholders of the Company, under the existing terms of appointment as previously approved, aside from the resolutions herein, until each of their successors is duly appointed and qualified, or until any of their earlier resignation or removal (voting took place in relation to each director nominee separately).

Proposal 2: To elect each of Ms. Alison Finger and Mr. Michael Rice as members of the Board, to serve until the next annual general meeting of shareholders of the Company or until each of their successors is duly appointed and qualified, or until their earlier resignation or removal, and to approve their compensation terms and equity grants.

Proposal 3: To approve the grant of options under the Company’s 2014 Employee Share Ownership and Option Plan according to the standard agreements as follows: (i) grant of an option to purchase 100,000 of our ordinary shares to Dr. Shapiro; (ii) grant of an option to purchase 45,000 of our ordinary shares to Ms. Alon; (iii) grant of an option to purchase 45,000 of our ordinary shares to Dr. Ben Zvi; (iv) grant of an option to purchase 45,000 of our ordinary shares to Dr. Cohen; and (v) grant of an option to purchase 45,000 of our ordinary shares to Mr. Hastings, each of which shall vest upon and in the manner approved by the Compensation Committee and the Board of Directors.

Proposal 4: To approve the increase Prof. Dror Harats’s monthly base compensation under the Consulting and Employment agreements, taken as a whole, to NIS 94,000, and to approve and ratify that the notice period for termination of Prof Harats under the Consulting and Employment agreements is nine months, as amended in in his Consulting agreement from 2007.

Proposal 5: To approve the re-appointment of Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Limited, as the Company’s independent registered public accounting firm for the year ending December 31, 2021, and until the next annual general meeting of shareholders of the Company and authorize the Board (with power of delegation to its Audit Committee) to fix the said independent registered public accounting firm’s remuneration in accordance with the volume and nature of its services.

Proposal 6: To approve the new compensation scheme for the Company’s non-employee, non-executive directors, or the Non-Employee Directors and the New Compensation Scheme, respectively as follows:

A. Cash Compensation

Board of Directors: Annual cash compensation of US$35,000 to each Non-Employee director, other than the Chairman of the Board and the former Chairman of the Board.
Audit Committee: Additional annual cash compensation of US$15,000 to the Chairman of the Audit Committee and US$7,500 to each member of the Audit Committee other than the Chairman.
Compensation Committee: Additional annual cash compensation of US$12,000 to the Chairman of the Compensation Committee and US$6,000 to each member of the Compensation Committee other than the Chairman.

Nominating and Corporate Governance Committee and other committees: Additional annual cash compensation of US$8,000 to the Chairman of the Nominating and Corporate Governance Committee or other committees and US$4,000 to each member of the Nominating and Corporate Governance Committee or other committees other than the Chairman.
Proration: Pro rata cash compensation of the annual cash compensation amounts set forth above shall be made, as applicable, to (i) any director who ceases to be a director, Chairman of the Board or member or chairman of any committee of the Board and (ii) any new Non-Employee director who is appointed by the Board, any independent director who is appointed to the position of Chairman of the Board or chairman of any such committee of the Board or any independent director who is appointed to serve on any such committee of the Board, for their services rendered as a director and/or committee member, for the portion of the year in which such director so served.


B. Equity Compensation

Initial Equity Grant: One-time equity grant upon initial appointment or election to the Board equal to 0.1% of the Company’s capital on a fully diluted basis as of the date of grant, which shall vest upon and in the manner approved by the Compensation Committee and the Board of Directors.
? Annual Equity Grant: Annual equity grants of 0.067% of the Company’s share capital on a fully diluted basis as of the date of grant to each continuing director, which shall vest upon and in the manner approved by the Compensation Committee and the Board of Directors.


C. In the event of any discrepancy between the New Compensation Scheme and the provisions of the Company’s 2019 Compensation Policy for Company Office Holders, the former shall prevail.

Based on voting results at the Meeting, the majority requirements for the proposals under the Israeli Companies Law 5759-1999 and the Articles, the above proposals were each properly approved at the Meeting.

This Report of Foreign Private Issuer on Form 6-K shall be incorporated by reference into VBL’s registration statements on Form F-3 (File Nos. 333-251821 and 333-238834), filed with the Securities and Exchange Commission on December 30, 2020 and April 19, 2021, respectively, to the extent not superseded by information subsequently filed or furnished (to the extent VBL expressly states that it incorporates such furnished information by reference) by VBL under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.

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VBL Therapeutics Announces Appointment of Sam Backenroth as Chief Financial Officer and Establishes Operations in the United States

https://finance.yahoo.com/news/vbl-therapeutics-announces-appointment-sam-120000308.html

Amos Ron to Retire as CFO and Will Continue to Serve as Corporate Secretary, Advisor to VBL

TEL AVIV, Israel and NEW YORK, Oct. 05, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced the appointment of Sam Backenroth as chief financial officer (CFO) effective immediately. Mr. Backenroth is an accomplished corporate finance veteran with demonstrated success in building and financing private and public biotechnology companies. In connection with the appointment, VBL established U.S. operations in New York, which will be managed by Mr. Backenroth, and he will be responsible for leading the company’s future financing and business development activities to support the company’s growth initiatives. Mr. Backenroth succeeds Mr. Amos Ron, who is retiring but will continue to serve as corporate secretary and in an advisory capacity.

“On behalf of the entire board of directors and management team, I want to thank Amos Ron for his outstanding service to VBL, and his leadership over the past decade. We are grateful Amos will continue as corporate secretary and an advisor to the company,” said Prof. Dror Harats, M.D., chief executive officer, VBL Therapeutics. “We are tremendously pleased to welcome Sam to the VBL executive leadership team and expand our operations in the United States. Sam has a proven track record in corporate finance, strategy, operations and business development. His leadership and strong investor and banking relationships will be invaluable as we as we enter a new era of innovation and growth for VBL as a leading global biotech company.”

Most recently, Mr. Backenroth was the chief financial officer at NeuBase Therapeutics (Nasdaq: NBSE), a novel genetic medicine platform company focused on rare genetic diseases and oncology. While at NeuBase, Mr. Backenroth helped build the finance and operations functions, took the company public, and raised approximately $100 million in equity capital.

"I am excited to join VBL to advance the company’s financial and business objectives and support its continued growth and development of its first-in-class pipeline of programs in oncology and immuno-inflammation. The company is at an exciting point, with the ongoing Phase 3 OVAL registration-enabling study of VB-111 in ovarian cancer advancing to the planned progression free survival readout in the second half of 2022 and the expected filing of an IND for the VB-601 MOSPD2 program in an immunology application in 2022,” said Mr. Backenroth. “VBL’s gene targeting precision medicine platform, coupled with its vision and expertise in biology, positions the company to make meaningful improvements to underserved patient populations and unlock significant shareholder value. I look forward to working with the team to capitalize on the tremendous potential for VBL to bring novel gene therapies to people living with cancer and immuno-inflammatory disorders.”

Prior to his tenure at NeuBase, Mr. Backenroth was the CFO of Ohr Pharmaceutical, where he was instrumental in the company’s growth from startup to a public market capitalization of several hundred million and helped move its lead program from preclinical into late-stage clinical development. He is also a founder of Orphion Therapeutics, a company focused on one-time gene therapy treatments for ocular and central nervous system manifestations of ultra-rare diseases, and DepYmed, Inc., a pharmaceutical company focused on a novel phosphatase inhibition technology platform for rare diseases and cancer, where he currently serves as a member of the Board of Directors. Mr. Backenroth began his career as an investment banker with The Benchmark Company LLC, where he raised capital and provided advisory services for biotechnology companies. Mr. Backenroth earned a bachelor of science degree in finance from Touro College in New York.

VBL has a burgeoning U.S. presence at both the board and executive level and its headquarters and manufacturing operations will continue to be located in Israel.

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VBL Therapeutics on go with Phase 3 VB-111 study in ovarian cancer after DSMC recommendation

Sep. 17, 2021 7:23 AM ETVascular Biogenics Ltd. (VBLT)

By: Mamta Mayani, SA News Editor

VBL Therapeutics (NASDAQ:VBLT) announces that the independent Data Safety Monitoring Committee (DSMC) of the ongoing OVAL Phase 3 study of VB-111 in ovarian cancer has conducted its fifth pre-planned review and has provided clearance to proceed with further clinical research as planned with no changes to the protocol.

The OVAL trial is planned to enroll ~400 adult patients globally and more than 320 patients (>80%) have already been recruited.

The trial has two primary endpoints: progression free survival (PFS) and overall survival (OS).

Successfully meeting either primary endpoint has the potential to support a biologics license application (BLA).

Meeting the PFS endpoint, with a readout anticipated in H2 2022, could accelerate BLA submission by approx. one year, based on the readout of the OS primary endpoint that remains anticipated in 2023.

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VBL Therapeutics Announces Independent Data Safety Monitoring Committee Provides Clearance to Continue the OVAL Phase 3 Registration-Enabling Study of VB-111 in Ovarian Cancer

https://finance.yahoo.com/news/vbl-therapeutics-announces-independent-data-110000328.html%

The OVAL Phase 3 clinical trial evaluating VB-111 in platinum-resistant ovarian cancer has recruited more than 320 patients (>80 %) to date;

Remains on track to complete enrollment in 1Q22[/url][tag]insert-text-here

TEL AVIV, Israel, Sept. 17, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ: VBLT) today announced that the independent Data Safety Monitoring Committee (DSMC) of the ongoing OVAL Phase 3 registration-enabling study of VB-111 in ovarian cancer has conducted its fifth pre-planned review and has provided clearance to proceed with further clinical research as planned with no changes to the protocol.

The independent DSMC for the OVAL trial is tasked with setting standards of safety, monitoring these standards’ implementation for the trial participants and treatment efficacy data, and acting on behalf of patients whenever necessary as the committee continues to monitor progress.

“We continue to be very pleased to learn that data collected to date in the OVAL clinical trial has passed independent DSMC review as we progress toward our enrollment goal,” said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. “We thank the DSMC for its ongoing diligence, guidance and support.”

The OVAL trial is planned to enroll approximately 400 adult patients globally and more than 320 patients (>80 percent) have already been recruited. The trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a biologics license application (BLA). Meeting the PFS endpoint, with a readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration (FDA), compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023.

About VB-111 (ofranergene obadenovec; `ofra-vec`)
VB-111 is an investigational anti-cancer, gene-therapy agent in development to treat a wide range of solid tumors. VB-111 is a unique biologic agent designed to use a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed in past clinical research to be generally well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received orphan designation for the treatment of ovarian cancer by the European Commission. VB-111 has also received orphan drug designation in both the United States and Europe, and fast track designation in the United States, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and platinum-resistant ovarian cancer (NCT01711970).

About the OVAL Trial (NCT03398655)
OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.

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VBL Therapeutics to Present at Upcoming Conferences
Vascular Biogenics Ltd.

https://finance.yahoo.com/news/vbl-therapeutics-present-upcoming-conferences-110000560.html

TEL AVIV, Israel, Sept. 10, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ: VBLT) today announced the Company will present in the following upcoming industry conferences:

H.C. Wainwright 23rd Annual Global Investment Conference
Mon., Sept. 13, 2021
Fireside chat available on-demand beginning at 7:00 a.m. ET

Cell & Gene Therapy World Asia 2021 conference
Wed., Sept. 15, 2021
Presentation Time: 4:45 PM (SGT)
Keynote Presentation Topic: VB-111: Transformative Gene therapy with the Potential to Change the Treatment Paradigm for Solid Tumors

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Wed., Sept. 22, 2021
Fireside chat at 1:15 PM - 1:55 PM (ET).

Webcasts will be available via the Events and Presentations section of the Company’s Investor Relations page.

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Vascular Biogenics Trial Nears Full Enrollment, Price Could Jump

Sep. 03, 2021 7:21 AM ETVascular Biogenics Ltd. (VBLT)1 Comment

Summary

Vascular Biogenics recently resumed dosing American patients in its OVAL Phase 3 trial.

Trial enrollment should complete in 1H 2022.

If the data is positive, the stock price should jump considerably.

Vascular Biogenics (VBLT), which operates as VBL therapeutics, is a small cap, clinical stage pharmaceutical company based in Israel. It is focused on cancer and inflammation. Its lead candidate is VBL-111 for ovarian cancer. As of the close on September 2, 2021, Vascular Biogenics had a stock price of $2.49, giving it a market capitalization approaching $144 million. The stock price has been volatile, extending from a 52-week low of $1.01 to a 52-week high of $3.17. I believe VB-111 has a solid chance of having a positive trial outcome and then becoming a commercial therapy. The current stock price appears to heavily discount that outcome. Given that enrollment for the VB-111 is approaching completion, I believe now is an opportune time to buy at a low price in hope of a good outcome.

Chart
Data by YCharts
VB-111 Oval Trial
Recently the VB-111 trial was paused from June 15 until August 30 while the FDA approved batches of the drug produced in a second facility in Modiin, Israel (See VBL Therapeutics Resumes Enrollment). The Oval ovarian cancer trial has currently recruited about 80% of its 400 patient target. VB-111, or ofranergene obadenovec, is a gene therapy delivered by adenovirus. It targets both tumor blood vessels and generates an anti-tumor immune response. It demonstrated proof-of-concept and survival benefit in its Phase 2 trial. A DSMC (Data and Safety Monitoring Committee) review of data is expected in the current quarter.

The endpoints of the Phase 3 Oval trial are PFS (progression free survival) and OS (overall survival). If enrollment proceeds as planned PFS could read out in the second half of 2022. While that might seem like a long wait for some investors, it is not far off for pharmaceutical development, and the stock price could rise in anticipation of the data and, before that, at completion of enrollment. If VB-111 is approved by the FDA and other regulatory agencies, it will be tested for other cancers. It has already demonstrated benefit in a Phase 2 radioiodine-refractory thyroid cancer trial. On the downside, it missed its endpoint in its Phase 3 glioblastoma trial, a notoriously difficult target cancer.

Q2 2021 Results and Cash Runway
Q2 2021 results for Vascular Biogenics were reported on August 16, 2021. Since Vascular has no commercial products, revenue was negligible. Expense for R&D and administration brought the net loss to $8.0 million, compared to a loss of $6.3 million in Q2 2021. That resulted in an EPS loss of $0.12. Cash and equivalents ended at $57 million. Taking $8 million per quarter as a cash burn rate, one year and three quarters remain. That would get the company through the Oval trial PFS data read out and is in line with guidance that cash should last until year-end 2023. If the PFS data is good, Vascular should be able to raise cash to complete the FDA process and take the therapy to market. If the PFS data fails to reach the statistical goal, the company would have to raise money to continue developing its earlier-stage assets, which would mean very substantial dilution to current stock holders.

Rest of Pipeline
While the main value at present is in the VBL-111 ovarian cancer indication, Vascular has a more extensive pipeline. The most important therapies target MOSPD2 for inflammation or cancers. The MOSPD2 inflammation program candidate, VB-601, has plans for Phase 1 trial initiation before the end of 2021. Preclinical data was presented an MOSPD2 antibody for multiple sclerosis at a science meeting in September 2020. The cancer version of MOSPD2 antibodies will be the bispecific VB-602. Preclinical data was presented at AACR in 2020.

Vascular also has an inflammatory disease program based on lecinoxoids. It includes VB-201 and VB-703. The work has mainly been preclinical, though VB-201 demonstrated reduction in atherosclerosis inflammation in an exploratory Phase 2 trial. Currently development of this program appears to be on the backburner.

Given the preclinical status of these programs, I do not expect them to have a significant impact on Vascular's value in the near future. Strong Phase 1 data with an MOSPD2 molecule, would modify that.

Conclusion
Vascular Biogenics has a low market capitalization for a company that might have an effective ovarian cancer therapy. I believe that is because it is relatively unknown, but what is known about it is the therapy failed for glioblastoma. Completion of enrollment in the Phase 3 VBL-111 trial would likely raise the company profile and stock price. Data to date is good, though that is no guarantee. While we will not know the outcome until the second half of 2022 or perhaps early 2023, the price is very attractive now. That is presuming you understand the risk and can withstand the impact if trial results are negative. Waiting for trial results is much safer, but if the results are positive, the price paid for the stock will be much higher.


Disclosure: I/we have a beneficial long position in the shares of VBLT either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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2.5300+0.1900 (+8.12%)
As of 12:17PM EDT. Market open.
Volume 613,385
Avg. Volume 499,936
Nice!

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VBL Therapeutics jumps 12% after resuming U.S. enrollment in late-stage OVAL trial

Aug. 30, 2021 7:38 AM ETVascular Biogenics Ltd. (VBLT)

By: Mamta Mayani, SA News Editor1 Comment

VBL Therapeutics (NASDAQ:VBLT) gains 11.5% premarket after announcing that enrollment of new patients in VB-111 studies in U.S. will resume immediately following authorization by the FDA Chemistry, Manufacturing and Controls (CMC) Group to use new batches of ofranergene obadenovec (VB-111), its commercial-scale facility located in Modiin, Israel.

In June, VBL was notified that clearance of new VB-111 batches for clinical use was pending the completion of a technical review, which focused on the comparability of VB-111 manufacturing between different source sites.

VBL has sufficient FDA-cleared batches and will resume patient recruitment in the OVAL trial in U.S.

The OVAL trial evaluating VB-111 in ovarian cancer is planned to enroll ~400 patients and nearly 80% of those have already been recruited.
The trial has two primary endpoints: progression free survival and overall survival.
Meeting the PFS endpoint, with a readout anticipated in H2 2022, could accelerate BLA submission by approx. one year.

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VBL Therapeutics Resumes U.S. Enrollment in OVAL Phase 3 Trial as FDA Authorizes Clinical Use of VB-111 Batches Produced in Modiin Facility

https://finance.yahoo.com/news/vbl-therapeutics-resumes-u-enrollment-110000885.html

U.S. FDA CMC clearance of VB-111 produced in Modiin, Israel facility an important milestone toward potential commercialization

OVAL Phase 3 trial evaluating VB-111 in platinum resistant ovarian cancer has recruited nearly 80% of target enrollment; remains on track to complete enrollment in 1Q22

OVAL PFS readout expected in 2H22 may support BLA submission

TEL AVIV, Israel, Aug. 30, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ: VBLT) today announced enrollment of new patients in VB-111 studies in the Unites States will resume immediately following authorization by the U.S. Food and Drug Administration (FDA) Chemistry, Manufacturing and Controls (CMC) Group to use new batches of ofranergene obadenovec (VB-111) produced in VBL’s commercial-scale GMP Modiin, Israel facility in clinical studies in the United States.

In June, VBL was notified by the FDA that clearance of new VB-111 batches for clinical use in the United States was pending the completion of a technical review by the CMC group, which focused on the comparability of VB-111 manufacturing between different source sites. VBL prepared and submitted the requested data and documentation to the FDA in early August and the FDA has now provided clearance for VBL to use new batches of VB-111 produced in its commercial-scale facility located in Modiin, Israel. VBL has sufficient FDA-cleared batches and will resume patient recruitment in the OVAL trial in the United States.

The OVAL trial evaluating VB-111 in ovarian cancer is planned to enroll approximately 400 patients globally and nearly 80% of patients have already been recruited. The trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a biologics license application (BLA). Meeting the PFS endpoint, with a readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the FDA, compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023.

About VB-111 (ofranergene obadenovec; `ofra-vec`)
VB-111 is an investigational anti-cancer gene-therapy agent in development to treat a wide range of solid tumors. VB-111 is a unique biologic agent designed to use a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed in past clinical research to be generally well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received orphan designation for the treatment of ovarian cancer by the European Commission. VB-111 has also received orphan drug designation in both the United States and Europe, and fast track designation in the United States, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).

About the OVAL Trial (NCT03398655)
OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized pivotal registration-enabling clinical trial comparing a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The trial is planned to enroll approximately 400 adult patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.

[Oren1976]

I gathered all the data I have and I came to the conclusion that they announce the success of the phase 3 in ovarian cancer this coming September

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Vascular Biogenics Ltd (VBLT) CEO Dror Harats on Q2 2021 Results - Earnings Call Transcript

Aug. 16, 2021 10:55 AM ETVascular Biogenics Ltd. (VBLT)

Vascular Biogenics Ltd (NASDAQ:VBLT) Q2 2021 Earnings Conference Call August 16, 2021 8:30 AM ET

Company Participants

Dror Harats - Chief Executive Officer

Amos Ron - Chief Financial Officer

Conference Call Participants

Etzer Darout - Guggenheim Securities

Susan Chor - Oppenheimer & Co

Ramakanth Swayampakula - H.C. Wainwright

Soumit Roy - Jones Trading

Operator

Greetings. Welcome to VBL Therapeutics Second Quarter 2021 Financial Results and Update Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded.

I will now turn the conference over to the VBL team. Thank you. You may begin.

Unidentified Company Representative

Thank you. Good morning, everyone, and thank you for joining today's VBL Therapeutics second quarter 2021 financial results and corporate update. Leading the call will be Professor Dror Harats, Chief Executive Officer; and Amos Ron, Chief Financial Officer. A press release of the company's financial results was issued earlier this morning and is available on the Investor Relations page of the company's website at vblrx.com.

Before turning the call over to management, I would like to remind everyone that during this conference call, forward-looking statements made by management are intended to fall within the Safe Harbor Provisions Act of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934 as amended. As set forth in our press release, forward-looking statements involve risks and uncertainties and that may affect the company's business and prospects, including those discussed in our filings with the SEC, which include,

among other things, our annual report on Form 20-F. These filings are available from the SEC or on our website.

Any forward-looking statements made on today's conference call speak only as of today's date, Monday, August 16, 2021, and the company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today's date. As a reminder, this call is being recorded and will be available for audio rebroadcast on the company's website. There will be a Q&A session following the company's prepared remarks.

With that, I'd like to turn the call over to Professor Harats. Please go ahead.

Dror Harats

Thank you, Eric, and good morning, everyone. Joining me on today's call is Amos Ron, our Chief Financial Officer, who will discuss the second quarter financial results for 2021.

We continue to make progress in our OVAL clinical trial, a registration-enabling Phase III study of VB-111 in ovarian cancer. The most significant event of the second quarter was the OVAL protocol change agreed upon with the U.S. FDA. Progression-free survival was added as a primary endpoint to the original overall survival end point. Successfully meeting either endpoint is expected to be sufficient to support a BLA submission. The details of the change were described in a presentation at this year's ASCO annual meeting in early June and the accompanying press release.

Successful meeting of the progression-free survival endpoint with the readout anticipated in the second half 2022 and has the potential to accelerate the BLA submission by approximately one year compared to original projections based on the readout of the overall survival primary endpoint, which remains anticipated in 2023. In addition to potentially shortening the time for the anticipated BLA submission, the protocol changes have several positive implications for the OVAL trial and VB-111's potential use as a treatment for platinum-resistant ovarian cancer.

First, including a second independent endpoint derisks the trial as we now have two shots on goal to obtain a result that will enable us to submit a BLA. Second, keeping the overall survival endpoint, preserve the opportunity to differentiate VB-111 from currently available ovarian cancer treatment which were approved based on progression-free survival data so far and did not show an overall survival benefit.

As part of our discussion with the U.S. FDA's CMC, the Chemistry Manufacturing and Controls group, it was agreed that VBL would provide additional data and documentation on new batches to be used in the OVAL study in the U.S. We submitted all requested materials to the agency in early August, and the CMC group is evaluating the data we sent them. At this point, we do not have an estimated timetable on when we will hear back from the agency regarding their review.

In the meantime, we took a precautionary step to reserve supply of FDA-approved batches of VB-111 for U.S. patients who are being actively treated in the OVAL study. And in June, we voluntarily paused enrollment of new U.S. patients. Existing patients enrolled in the U.S. continue on protocol and enrollment continues in Europe, Israel and Japan. Despite the temporary pause in U.S. enrollment, we maintain our expectations with respect to the timing of the PFS data readout in the second half of 2022.

Our next milestone for OVAL is the upcoming DSMC review expected this quarter. This time, it will include review of 75% of the study population, that is about 300 patients. To date, we have had three successful DSMC reviews of the study. The most recent one was in February of this year. Following the review, which looked at 200 patients, the DSMC again gave us a green light to proceed as planned.

In the second quarter, we also significantly strengthened our cash position. Earlier in the quarter, we closed a public equity offering at market price to raise net proceeds of $26.4 million from existing shareholders as well as institutional funds from the U.S. and Israel. Together with the additional of $12.3 million that was injected into the company during the first quarter, mostly through the existing of warrants that were issued in 2020, we now have more than $57 million on hand. These funds are expected to cover the company until the year-end 2023, which is beyond clinical readouts in OVAL and the potential BLA submission of the VB-111 in ovarian cancer.

As VBL prepares for success and potential commercialization of VB-111, we had a few changes to our Board of Directors. We are happy to welcome Alison Finger and Michael Rice to our Board. Alison was previously the Chief Commercial Officer at Bluebird Bio and has extensive experience in global product commercialization, including commercialization of gene and cell therapy products at Bluebird. Michael's experience in health care capital markets will be critical to VBL as we approach the disclosure of top line data from OVAL and as we plan to execute our strategic and operational objectives in bringing VB-111 to patients.

Finally, our planned succession for the Chairmanship of our Board was recently completed. Marc Kozin, who joined our Board as Vice Chairman last October, is now our Chairman. Dr. Bennett Shapiro stepped down as the Chairman, but will continue to contribute to VBL as a member of our Board.

Before I hand the call over to our Chief Financial Officer, Amos Ron, I would like to say that we have continued our momentum from 2020 into the first half of 2021 and are optimistic about the second half of this year. We are encouraged by the significant investments of VB-111, and I look forward to sharing updates on our ongoing programs through the rest of the year.

With that, I will hand off the call to Amos, who will discuss the financial results for the second quarter. Thank you.

Amos Ron

Thank you, Dror, and good morning, everyone. As of June 30, 2021, we had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $57.2 million and working capital of $49.2 million. We expect that our cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements until year-end 2020.

Revenues for the second quarter were $188,000 as compared to $158,000 for the comparable period in 2020. R&D expenses net was $6.6 million for the fiscal year compared to $4.7 million in the same period in 2020. General and administrative expenses was $1.5 million for the second quarter compared to $1.3 million in the same period in 2020. And finally, comprehensive loss for the second quarter was $8 million or $0.12 per basic share compared to $5.8 million or $0.14 per share -- per basic share in the comparable period in 2020.

With that, I will turn the call back to the operator for the Q&A portion of this morning call. Thank you.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question is from Etzer Darout with Guggenheim. Please proceed.

Etzer Darout

Great. Just a couple on sort of the VB-111. I guess the first is, does the precautionary pause of U.S. patients, does that change the nature of the update in the third quarter by the DSMC? And I guess, similarly, with respect to sort of the investigator glioblastoma trial, if there's sort of any impact on that study sort of concerning sort of the batches for that study?

Dror Harats

Thank you, Etzer. Actually, the pause that we were voluntarily took not to recruit new patients in the United States or to screen for a new patient in United States was done mainly because we know that there are patients on the trial right now using the batches that are already approved by the FDA for this study. And we don't want to be in a position that the patient is responding to VB-111 and we know that some patients are actually staying on the drug for quite a long time, and we will be in a position that we want to have a supply to give to these patients. And therefore, we voluntarily took this step. But this step is not going to affect the DSMC review, because the DSMC review was a cutting 0.8 that was not affected at all by this. And if any, just when we announce to the centers that we are going to stop screening, you can imagine that they had a list of patients that they wanted to recruit to the trial, and they actually recruited quite a significant amount of patients. So the review is going to be done off a bit over 300 patients, which is about 75% of the patient population of the trial.

Regarding the other two trials that we are running. The one that we are running with the NCI in colon cancer is not affected in any way by this event because they have enough supply for what they need for the trial. But in the GBM trial, we're also not screening for new patients because we just were in a position that we were about to open more centers, and we didn't want to open them before we know that we have the batches approved to go. Now the drug is already in the U.S., waiting for the final approval from the CMC. And the moment that we will get it, we will be able to open back post recruitment for the OVAL and for the GBM trial.

Operator

Our next question is from Kevin DeGreeter there with Oppenheimer.

Susan Chor

This is Susan on for Kevin. Just a couple of questions. First, just a modeling question. Is the step within R&D expected to last for the rest of the year? Is 6.6 million new baseline?

Dror Harats

Can you repeat the question? We couldn't hear you well.

Susan Chor

Sorry. Let me try again. Is the R&D spend for this quarter the new baseline for the remainder of the year?

Amos Ron

Are you referring to the increase in R&D expenses for the quarter?

Susan Chor

Yes.

Amos Ron

Yes. Okay. So we do not expect the current or this quarter run rate to continue for the full year. We expect to be in line with our average of about $2 million or a little less per month run rate on the year. And the total R&D expenses for the year will be a bit higher than last year, because we are advancing the VB-601. And the oral study is gearing up, but not in the portion that was evident in the quarter.

Susan Chor

A follow-up question on VB-111 enrollment. So I think in June, you guys had enrolled 300 patients. Can you provide an update on the number of patients enrolled?

Dror Harats

We don't provide it on a regular basis. Usually, we provide it when we get to significant numbers. So I would prefer not to say the number right now, but we keep on progressing. Of course, we are not screening now in the U.S. So the pace is a bit slower, but we believe that we can actually -- if things will work well with the CMC, we will be able to meet the time line of finished recruiting by year-end or beginning of next year.

Susan Chor

Great. And just one last question. Did the FDA provide any guidance on the review process? And I guess my follow-up to that is, is there any kind of on-site inspection that might delay time lines?

Dror Harats

No. We don't expect any on-site inspection. You know that usually, the on-site inspection is coming when you submit the BLA. Of course, it was -- the FDA wanted to know a lot of information, in our case, before we submit the BLA, and I believe that one of the reason is because we were shortening the time for potential BLA, but it's all done in data that we are sending them and documentation. There is no on-site visit. The FDA actually guided us quite thoroughly on what exactly they need to see in the status that we are sending them. And we believe that we send them all this information at the beginning of the month. We know that they are working on it right now and reviewing it. And we've been assured that they will come back to us at the moment that they will review this step.

Susan Chor

That's all the questions from us.

Operator

Our next question is from RK with H.C. Wainwright. Please proceed.

Ramakanth Swayampakula

Dror and Amos, regarding the precautionary pause that you're taking on the U.S. side in terms of enrollment, do you -- what commentary do you have on if there is a potential impact on the statistics or in the population mix when you get to the final analysis of the oral study.

Dror Harats

I don't think -- that's a very good question, but I don't think that it will have an effect on either the statistics or the overall population. When we took this step, we already had the majority of patients coming from the U.S. So there won't be an issue of where the majority of patients coming from because you know that that's part of the thing that the FDA will want to see and they know that the majority of patients coming from the U.S. anyway. The second thing is that there is no real big change in the pace of recruitment because just before this pause, as I was saying before, we had quite significant amount of patients that were screened.

So our plan was, all of the time -- our statistical plan was all the time assuming that we will be fully recruited by first quarter 2022. And because we knew that we are recruiting better than anticipated, we were saying year-end. So I don't think it will change any of the statistics or if it will change any of the mix of population that we will have.

Ramakanth Swayampakula

And then for the people that you've already recruited in the U.S., is the shelf life of the drug long enough in case some of these patients need to stay on the drug for longer than anticipated?

Dror Harats

Shelf life that we have for VB-111, now if I recall right, it's about 5 years. That's a very long shelf life, and we don't have any issue. I believe it was 4.5%, and we are extending it right now, but we have no issue with shelf life. And by the way, we have no issue with production. We are making more batches and some of the batches will be already for the commercial and batches all looks very well. So it was only the issue of showing that the new facility and the release lab are actually comparable to what was done in the other site.

Ramakanth Swayampakula

My last question is any commentary on the colorectal cancer and the recurrent GBM studies in terms of the progress? And also any update on the time lines at all in terms of data expectations?

Amos Ron

So the colon cancer is -- continue as planned. And as you all know, we agreed with the National Cancer Institute doctors that we will actually look at biopsies to see if indeed we are turning the cold tumor off the colon into a hot tumor, meaning that we have inflammation there and a lot of CD4 and CD8 cells. For that, we need enough biopsies where the patients are on VB-111 alone and when they are on combined therapy. As you can imagine, patients that's going on trial like this at NCI are quite advanced in their disease. And we are collecting enough patients and enough biopsies for that. And the moment that we will have it and that we will have data on the histology, of course, we will share it with the market. The point that the study is ongoing and the point that it takes time. I don't think that's a bad signal, but I don't have more information about that.

Regarding the GBM trial, some centers are open, some centers are ready to open. But again, for the sake of the patients that are on the OVAL trial, we didn't want to use any of the material that is already approved by the agency to use in the U.S. for clinical trials, for any trial, except for the patients that are on the OVAL trial and getting VB-111 because there are a significant amount of patients that are actually on the drug, and we have to make sure that we have enough supply for them.

Operator

[Operator Instructions] Our next question is from Soumit Roy with Jones Trading. Please proceed.

Soumit Roy

Congrats on the progress. If you could just give us a little color on what percent of patients are from the U.S. versus ex U.S. and how many sites U.S. versus ex U.S.? And second is, if you have any idea on what the patients are -- what kind of treatment they would undergo post relapse? And if there is a possibility of redosing a stable patient, if that's -- mechanistically, it makes sense?

Dror Harats

Yes. So thank you, Sumit, for the question. In the U.S. we do have over 200 patients out of these 300 patients. So the majority are coming from the U.S. There is no question about it. There are about 64 sites in the U.S. alone. So we are talking about majority of sites coming from the U.S. as you can you imagine. We also have a significant number of sites in Israel, in Japan and in Europe, but the study was planned from the beginning to have the majority of patients from the U.S. What was your second question?

Soumit Roy

Does it make sense mechanistically to be able to redose these patients for stable disease patients? Or that's not something you -- because of vector or antibody development won't allow?

Dror Harats

No, no. Actually, the antibodies does not prevent the drug from working because it takes about a few cycles of the drug in the blood to get into the endothelial cells and they stay actually quite protected and the gene is there for a very long period of time. And we showed it both in animal models and in human being when we had a chance to biopsy from tumors. The expression of the drug is quite significant for a long period of time, and we could see responses in recurrent dosing. So there is no question that you can give it in a recurrent dosing. And actually, that's why we are treating the patient every 8 weeks until progression. And we allow in the OVAL trial to actually treat beyond progression until we are sure that this is real progression and not to pseudo progression.

And in the colon study, we're giving the drug every 6 weeks, not every 8 weeks. So we are giving the drug in -- as a repeated dosing until the patient progressed. When they progressed, theoretically, I think that what should be given is checkpoint inhibitors because maybe one of the reasons theoretically that the patient would progress is that we induce the immune system there or brought it there. But then the checkpoint inhibition by the tumor restart working. But we cannot control it because it's not part of the trial of the OVAL trial. It is part of the colon study at NCI, where we combined it with checkpoint inhibitors. So if you ask me what the doctors do when the patient progress, as far as I know, they go on chemotherapy, they try to put them sometime a radiation, but there is no real treatment for platinum-resistant of ovarian cancer.

Soumit Roy

Congrats on the progress.

Dror Harats

Thank you very much.

Operator

This does conclude our question-and-answer session. I would like to turn the conference back over to the VBL team for closing comments.

Dror Harats

So thank you all for joining us on today's call, and have a wonderful day. Thank you.

Operator

Thank you. This does conclude today's conference. You may disconnect your lines at this time. And thank you for your participation.

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VBL Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Update

https://finance.yahoo.com/news/vbl-therapeutics-reports-second-quarter-110000416.html

Conference Call and Webcast at 8:30 a.m. EDT Today

Closed public offering raising net proceeds of $26.4 million; cash position is expected to fund operations until year-end 2023, through readout from the OVAL study and potential Biologics License Application (BLA) submission for VB-111 in ovarian cancer

Announced amendment to primary endpoint in OVAL study to include progression free survival (PFS); PFS data expected in second half of 2022; next Data and Safety Monitoring Committee (DSMC) review expected 3Q21

Prepared and submitted requested VB-111 Chemistry, Manufacturing, and Controls (CMC) documentation to the FDA in early August; currently awaiting FDA guidance on use of new batches

TEL AVIV, Israel, Aug. 16, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the second quarter ended June 30, 2021, and provided a corporate update.

“With $57.2 million in cash that is projected to fund our operations until year-end 2023, we are excited to advance our OVAL study, with PFS as its additional primary endpoint, towards clinical readout in the second half of 2022,” said Dror Harats, M.D., Chief Executive Officer of VBL. “Following the FDA request for additional technical production data on VB-111, we prepared and submitted the requested information in early August and are currently awaiting agency guidance. With several important milestones anticipated through the rest of 2021, we look forward to keeping investors apprised of our progress.”

Second Quarter and Recent Corporate Highlights

VB-111

In June, VBL presented an update on the progress of the OVAL Phase 3 registration-enabling study of VB-111 in ovarian cancer at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation announced an amendment to the primary endpoint in the OVAL study to include a second, separate primary endpoint of PFS in addition to the original primary endpoint of overall survival (OS).

As part of VBL’s discussion with the Chemistry, Manufacturing, and Controls (CMC) group of the FDA on VB-111 production, it was agreed that VBL would provide additional documentation on new batches to be used in the OVAL study. VBL prepared and submitted the requested documentation to the FDA in early August and is currently awaiting agency guidance.

As a precautionary step to preserve supply of FDA-approved batches, in June, VBL voluntarily paused enrollment of new U.S. patients in the OVAL study. Existing patients enrolled in the United States continue on protocol and enrollment continues in Europe, Israel, and in recently opened sites in Japan.

Corporate

In April, VBL closed a public offering raising net proceeds of $26.4 million. The Company’s cash position is expected to fund operations until year-end 2023, through the readout from the OVAL study and potential BLA submission for VB-111 in ovarian cancer.

In July, VBL announced the appointments of Alison Finger and Michael Rice to its Board of Directors.

In July, the planned succession for Chairmanship of VBL’s Board of Directors was completed. Marc Kozin, who joined the Board as Vice Chairman in October 2020 was appointed Chairman. Former Chairman, Dr. Bennett Shapiro, stepped down as Chairman but will remain a Director.

Financial Results for the Second Quarter 2021

As of June 30, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $57.2 million. In April 2021, VBL raised net proceeds of $26.4 million in a public offering of shares and pre-funded warrants (including partial exercise of the underwriters’ overallotment option). VBL expects that its cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements until year-end 2023.

Revenues for the second quarter 2021 were $188 thousand, as compared to $158 thousand in the comparable period in 2020.

R&D expenses, net, were $6.6 million for the second quarter compared to $4.7 million in the comparable period in 2020. This increase is due to the clinical development activity of VB-111 for ovarian cancer, in addition to the advancement of VB-601 toward Investigational New Drug Application (IND) submission.

G&A expenses were $1.5 million for the second quarter compared to $1.3 million in the comparable period in 2020.

VBL reported a net loss for the quarter ended June 30, 2021, of $8.0 million, or ($0.12) per basic share, compared to a net loss of $5.8 million, or ($0.14) per basic share, in the comparable period in 2020.

Conference Call and Webcast:
Monday, August 16 at 8:30 a.m. EDT
Conference ID: 13721456
From the US: 1 877 407 9208
Israel Local: 1 809 406 247
International: 1 201 493 6784
Webcast: https://edge.media-server.com/mmc/p/9trg9snq

The live webcast will be available online and may be accessed from the “Events and Presentation” page of VBL's website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

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VBL Therapeutics Q2 2021 Earnings Preview

Aug. 15, 2021 2:04 AM ETVascular Biogenics Ltd. (VBLT)

By: Gaurav Batavia, SA News Editor

VBL Therapeutics (NASDAQ:VBLT) is scheduled to announce Q2 earnings results on Monday, August 16th, before market open.

The consensus EPS Estimate is -$0.10 (+28.6% Y/Y) and the consensus Revenue Estimate is $0.28M (+75.0% Y/Y).

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Vascular Biogenics Ltd. (NASDAQ:VBLT) Expected to Announce Quarterly Sales of $370,000.00

Posted by Stephan Byrd on Aug 6th, 2021

https://www.tickerreport.com/banking-finance/7738197/vascular-biogenics-ltd-nasdaqvblt-expected-to-announce-quarterly-sales-of-370000-00-3.html

Vascular Biogenics logoEquities analysts expect that Vascular Biogenics Ltd. (NASDAQ:VBLT) will post sales of $370,000.00 for the current fiscal quarter, according to Zacks. Three analysts have made estimates for Vascular Biogenics’ earnings. The lowest sales estimate is $200,000.00 and the highest is $700,000.00. Vascular Biogenics reported sales of $160,000.00 in the same quarter last year, which indicates a positive year-over-year growth rate of 131.3%. The business is scheduled to issue its next earnings results on Thursday, August 12th.

According to Zacks, analysts expect that Vascular Biogenics will report full year sales of $760,000.00 for the current financial year, with estimates ranging from $600,000.00 to $900,000.00. For the next financial year, analysts anticipate that the business will post sales of $2.90 million, with estimates ranging from $600,000.00 to $7.39 million. Zacks’ sales averages are an average based on a survey of sell-side research firms that cover Vascular Biogenics.

Vascular Biogenics (NASDAQ:VBLT) last released its quarterly earnings results on Monday, May 10th. The biopharmaceutical company reported ($0.12) earnings per share (EPS) for the quarter, topping the Thomson Reuters’ consensus estimate of ($0.13) by $0.01. The company had revenue of $0.19 million during the quarter, compared to analysts’ expectations of $0.20 million. Vascular Biogenics had a negative return on equity of 68.79% and a negative net margin of 3,394.74%.

Several analysts have recently weighed in on VBLT shares. Chardan Capital restated a “buy” rating and issued a $5.00 price objective on shares of Vascular Biogenics in a report on Thursday, June 3rd. Guggenheim started coverage on Vascular Biogenics in a report on Tuesday, May 18th. They issued a “buy” rating and a $7.00 price objective for the company. Zacks Investment Research lowered Vascular Biogenics from a “buy” rating to a “hold” rating in a report on Tuesday, July 13th. Finally, Roth Capital upped their price objective on Vascular Biogenics from $5.00 to $7.00 and gave the company a “buy” rating in a report on Thursday, June 3rd. One equities research analyst has rated the stock with a hold rating and four have issued a buy rating to the stock. The company currently has a consensus rating of “Buy” and a consensus target price of $5.10.
Shares of Vascular Biogenics stock traded down $0.02 during trading on Friday, hitting $2.18. The stock had a trading volume of 262,530 shares, compared to its average volume of 774,060. The stock has a market capitalization of $105.05 million, a price-to-earnings ratio of -4.11 and a beta of 0.99. The firm’s fifty day simple moving average is $2.34. Vascular Biogenics has a fifty-two week low of $1.01 and a fifty-two week high of $3.17.

Several hedge funds and other institutional investors have recently made changes to their positions in the company. Ikarian Capital LLC purchased a new stake in shares of Vascular Biogenics during the first quarter valued at $1,601,000. Squarepoint Ops LLC purchased a new stake in shares of Vascular Biogenics during the first quarter valued at $229,000. PVG Asset Management Corp purchased a new stake in shares of Vascular Biogenics during the first quarter valued at $53,000. Bank of New York Mellon Corp acquired a new position in Vascular Biogenics during the fourth quarter valued at $47,000. Finally, Steel Peak Wealth Management LLC acquired a new position in Vascular Biogenics during the first quarter valued at $48,000. 5.58% of the stock is owned by institutional investors and hedge funds.

About Vascular Biogenics

Vascular Biogenics Ltd., a clinical biopharmaceutical company, focuses on the discovery, development, and commercialization of treatments for cancer and immune/inflammatory indications. The company's program is based on its proprietary vascular targeting system platform technology, which utilizes genetically targeted therapy to destroy newly formed or angiogenic blood vessels.

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Vascular Biogenics Ltd. (NASDAQ: VBLT)

https://finance.yahoo.com/news/10-biotech-penny-stocks-buy-142044490.html

Number of Hedge Fund Holders: 2 Price as of August 6, 2021: $2.20 per share

Vascular Biogenics Ltd. (NASDAQ: VBLT) is a biotechnology company that focuses on the development and marketing of drugs for treatment of cancer. The firm is based in Israel and is ranked ninth on our list of 10 biotech penny stocks to buy according to Reddit. In earnings results for the first quarter, posted on May 11, the firm reported earnings per share of -$0.12, beating market expectations by $0.01. On June 3, the stock soared 8% on the back of positive reaction to an amendment to a Phase 3 study into a cancer drug.

On May 18, investment advisory Guggenheim assumed coverage of Vascular Biogenics Ltd. (NASDAQ: VBLT) stock with a Buy rating and a price target of $7. Etzer Darout, an analyst at the firm, issued the ratings update.

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VBL Therapeutics to Report Second Quarter Financial Results on August 16
Vascular Biogenics Ltd.

https://finance.yahoo.com/news/vbl-therapeutics-report-second-quarter-110000033.html

Thu, August 5, 2021, 2:00 PM

TEL AVIV, Israel, Aug. 05, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) will release its second quarter financial results for the period ended June 30, 2021 on Monday, August 16 before market open. Professor Dror Harats, M.D, Chief Executive Officer and Amos Ron, Chief Financial Officer, will host a conference call at 8:30am EDT the same day to discuss the results and provide a corporate update.

Conference Call:

Monday, August 16, 2021 at 8:30am EDT

Conference ID: 13721456

US: 1 877 407 9208

Israel Local: 1 809 406 247

International: 1 201 493 6784

Webcast: https://edge.media-server.com/mmc/p/9trg9snq

About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a publicly traded (Nasdaq: VBLT), clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune- or inflammatory-related indications. The VBL Therapeutics pipeline has been developed utilizing the company’s three proprietary platform technologies: a gene therapy-based platform technology targeting newly formed blood vessels, an antibody-based technology platform targeting MOSPD2 (motile sperm domain containing 2) and a lecinoxoids platform comprised of a family of small-molecules. The company’s lead oncology candidate, VB-111 (ofranergene obadenovec; `ofra-vec`), is an investigational, first-in-class, targeted anti-cancer gene-therapy agent in development to treat a wide range of solid tumors. VB-111 is currently being studied in a phase 3 potential registration trial for platinum-resistant ovarian cancer.

CONTACT:
Burns McClellan for VBL Therapeutics
Lee Roth & Eric Ando (Investors)
[e-mail] & [e-mail]
[phone]

Robert Flamm & Harrison Wong (Media)
[e-mail] & [e-mail]
[phone]

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VBL Therapeutics Provides Update on OVAL, a Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer

https://finance.yahoo.com/news/vbl-therapeutics-provides-oval-phase-110000759.html

TEL AVIV, Israel, June 15, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today provided an update on its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer.

The Company was notified by the U.S Food and Drug Administration (FDA) that clearance of new VB-111 batches for use in the U.S. is currently pending the completion of a technical review by the Chemistry, Manufacturing, and Controls (CMC) group, which is evaluating the comparability of VB-111 manufacturing between different source sites.
Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S. Accordingly, recruitment of new patients in the U.S. will be temporarily paused. Treatment will continue as usual for all U.S. patients currently enrolled. To-date, the study has enrolled approximately 75% of the planned 400-patients.

“Our team is working to provide the requested information to the FDA as quickly as possible,” said Dror Harats, M.D., CEO of VBL Therapeutics. “Since receipt of the notification, we have submitted some of the requested information, and are preparing the remaining documentation, which we believe can be completed and submitted to the agency in the next two to three months. We do not expect a material change to our data readout timelines. We are in regular contact with the FDA and taking the steps necessary to minimize disruption to the trial in the U.S.”

VBL recently amended the primary endpoint of OVAL based upon requested changes by the Company that were reviewed by the FDA. OVAL now includes a second, separate primary endpoint, of progression free survival (PFS), in addition to the original primary endpoint of the trial, overall survival (OS). Successfully meeting either primary endpoint is expected to be sufficient to support BLA submission.

About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal registration enabling clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.

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Vascular Biogenics trades lower after an update on ovarian cancer study

Jun. 15, 2021 7:37 AM ETVascular Biogenics Ltd. (VBLT)
By: Dulan Lokuwithana, SA News Editor

Vascular Biogenics (NASDAQ:VBLT), operating as VBL Therapeutics has paused the recruitment of new patients in the U.S. for its ongoing OVAL Phase 3 study designed to investigate ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer. Vascular Biogenics has lost ~9.7% in the pre-market.

The OVAL study has enrolled nearly 75% of the planned 400-patients to date. The FDA has informed the company that the regulatory clearance of new VB-111 batches for use in the U.S. is pending the completion of a technical review.

“Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S.” VBL Therapeutics said in the statement adding that the treatment will continue as usual for all currently enrolled U.S. patients.

Early this month, VBL Therapeutics announced an amendment to the study adding a second, separate primary endpoint to measure the progression-free survival (PFS).

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VBL Therapeutics: Feeling Bullish After VB-111 Clinical Trial Amendment

Jun. 10, 2021 9:15 PM ETVascular Biogenics Ltd. (VBLT)

Summary

VBL Therapeutics recently announced that they were allowed to add progression-free survival as a second primary endpoint for VB-111's Phase III OVAL study in ovarian cancer.

The addition of the PFS endpoint could reduce VB-111's regulatory timeline by one year. Thus, moving VBL closer to commercialization.
I reveal my plans for managing my VBLT position.

VBL Therapeutics (Vascular Biogenics Ltd. (VBLT)) continues to progress their flagship candidate, VB-111, an innovative gene therapy for solid tumors. Recently, the company announced that their Phase III OVAL pivotal trial in ovarian cancer has been amended to add progression-free survival “PFS” as an additional primary endpoint. This amendment could hasten their BLA submission and move the regulatory finish line significantly closer. This news was embraced by the market and the share price responded positively. For me, I see the amendment to be an extremely bullish event for the company and improves the likelihood that VB-111 gets the thumbs up from the FDA.

I intend to review the VB-111 program for ovarian cancer and will explain how this update impacts the regulatory process. In addition, I will discuss why this has amplified my bullish near term and long-term outlook for VBLT.

Background on VB-111 Ovarian

VBL’s VB-111 is a gene therapy candidate that targets the diagnosed cancer by blocking the tumor’s vasculature and stimulates the immune system to attack the tumor. What is more, VB-111 has the prospects to work on any tumor mutation, so it is possible that it is effective against all solid tumors.

https://static.seekingalpha.com/uploads/2021/2/27/48523746-16144819997440276.jpg

Figure 1: VBL-111 MOA (Source: VBLT)

VB-111’s Phase III OVAL study in platinum-resistant ovarian cancer is moving closer to the finish line. So far, VB-111’s data has been impressive with a 58% or higher response rate, which is significantly higher than standard-of-care treatments for which response rate is stuck between 10% and 20% (Figure 2).

Figure 2: VB-111 ORR (Source: VBLT)

In addition to the strong data, VB-111 has several other advantages over some of the other leading treatments (Figure 3). Personally, I would like to point out the advantageous IV dosing regimen of every 8 weeks, which would be an improvement over AVASTIN’s IV every 2-3 weeks (Figure 3).

https://static.seekingalpha.com/uploads/2021/2/27/48523746-1614482000013393.jpg

Figure 3: VB-111 vs. Ovarian Competition (Source: VBLT)

In terms of safety, the DSMC saw “no safety issues with the trial and recommended its continuation as planned.” The next DSMC review is expected to occur during Q3 of this year. As for enrollment, the company reported that they have about 2/3 of the patients needed and should be fully enrolled by year-end (Figure 4).

Figure 4: OVAL Enrollment Status (Source: VBLT)

Amendment

Recently, VBL publicized the primary endpoint amendment of VB-111’s OVAL Phase III study. The clinical trial now has two separate primary endpoints, of progression-free survival and overall survival “OS”. To review, overall survival is if the patient has not died from any cause, whereas progression-free survival is survival without progression of the disease.

VBL believes that either primary endpoint is anticipated to be adequate to warrant a BLA submission. The PFS endpoint is expected to have a readout in 2022, which could hasten BLA submission by roughly one year compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023.

Why is this significant?

The PFS endpoint will show VB-111's potential to prevent the disease/symptoms from getting worse, whereas, overall survival will demonstrate how patients who are on VB-111 + paclitaxel live longer than patients who are taking placebo + paclitaxel. The OS endpoint is obviously the end-all of endpoints because most patients want to live longer. However, OS is a broad endpoint and doesn't always tell the whole story. The PFS endpoint should reveal how a patient is living/dealing with cancer. It is one thing to live longer with cancer, but it is also important to live longer without dealing with deteriorating health and amplifying symptoms.

Another positive result of having another primary endpoint is that it will provide some insurance if the data from one of the endpoints falls short. This way, VBL, and VB-111 will be able to use the successful endpoint and still have a shot at approval. Moreover, the addition of PFS should fast-track the clinical readout and to a potential approval because the PFS data is anticipated to be revealed in 2022 vs 2023 for an OS readout.

What is more, the fact the company was able to keep the OS as a primary endpoint should be applauded. Having an OS as a primary endpoint will offer them the opportunity to distinguish VB-111 from contemporary ovarian cancer treatments, of which the majority were approved on their PFS data (Figure 3). Not only would this help in terms of an approval, but would be a great selling point when on the market.

Amplified Bullish Outlook
The endpoint amendment has amplified my bullish outlook for VBLT in the near term and long term. I believe that if approved, VB-111 has the potential to reform cancer therapeutics and possibly launch a new standard of care in several cancers. Now with the PFS endpoint, we could see VB-111 on the market one year earlier than expected, which could lead to an earlier launch and influx of revenues. As a result, we would have one less year of “all burn and no earn” in the financial statements.

This is an important point because the company now has over $60M in cash, which is expected to fund the company until year-end 2023. So, it is now possible that we could see a Phase III readout and a BLA before the company has to pull a trigger on another offering. Prior to the endpoint amendment, I was anticipating two secondary offerings before a potential approval. Now, we might only see one financing deal before a potential approval and executed at a higher valuation.

Indeed, it is hard to accept that simply adding the PFS endpoint to the trial has significantly amplified my bullishness. However, I believe this simple update has improved VB-111’s chances of approval, shortened the regulatory timeline, moved the company closer to pulling in some revenue, and provided a key data point to use in commercialization. Essentially, almost everything improved for VB-111’s regulatory and commercial prospects.

Plan
In my previous VBLT article, I discussed how I was going to make a technical entry and add once the company hits key milestones. Unfortunately, VBLT’s daily chart (Figure 5) did not give me that clear signal I was looking for, so I never amassed the position size I was hoping to have at this time. Admittedly, I wasn’t looking to “load up” at this point in time because of the lack of a clear completion date for OVAL and the impending threat of dilution.

Figure 5: VBLT Daily (Source: VBLT)

Now with some extra cash in the bank and a potentially reduced time to a PDUFA date, I will be looking to add on dips and selling on rips to accumulate an upsized position while still banking profits. Long term, I am still willing to give VBLT at least five years to get VB-111 on the market for ovarian and at least two other oncology indications. On the other hand, if VB-111 fails to hit the OVAL endpoints, I will liquidate my position and will revisit the ticker after the company decides their next course of action.

After years of working in the medical field, I have developed a passion for biotech and lifesaving therapies. Now, I am a full-time biotech investor who is in search of the next breakthrough therapy, device, or pharmaceutical. My trade focus is around catalysts and potential acquisitions.

Disclosure: I am/we are long VBLT. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

[midastouch017]

VBL Therapeutics Announces Addition of Progression Free Survival as a Second Primary Endpoint in OVAL, a Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer

https://finance.yahoo.com/news/vbl-therapeutics-announces-addition-progression-110000831.html


Second primary endpoint added following discussion with the U.S. Food and Drug Administration

Successfully meeting either PFS or OS primary endpoints expected to be sufficient for submitting a BLA for potential full FDA approval

PFS endpoint readout expected in 2022; BLA submission could be possible one year earlier than previously projected with OS endpoint alone

Clinical trial amendment reported in an OVAL Clinical Trial in Progress poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

TEL AVIV, Israel, June 03, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced a primary endpoint amendment in the OVAL Phase 3 registration-enabling study of VB-111. The clinical trial amendment included a second, separate primary endpoint, of progression free survival (PFS), in addition to the original primary endpoint of the trial, overall survival (OS). Based upon the changes that were reviewed by the U.S. Food and Drug Administration (FDA), successfully meeting either primary endpoint is expected to be sufficient to support BLA submission. Successful meeting of the PFS endpoint, with a readout anticipated in 2022, could accelerate BLA submission by approximately one year compared to original projections based on the readout of the OS primary endpoint that remains anticipated in 2023. The OVAL study amendment, along with an update on the number of patients enrolled, which as of April 30, 2021, exceeded 260 patients, will be presented tomorrow as part of a virtual Clinical Trial in Progress poster presentation at the 2021 ASCO Annual Meeting.

“The addition of PFS as a second independent primary endpoint has several very important implications on the OVAL study,” said Bradley Monk, M.D., FACS, FACOG, Arizona Oncology (U.S. Oncology Network), and Chair of the OVAL Study Steering Committee. “First, it de-risks the study, as it provides two options for study success. Second, it should accelerate the time to clinical readout and to potential approval, as PFS data are expected during 2022. Third, keeping OS as a primary endpoint preserves the opportunity of differentiating VB-111 from current ovarian cancer treatments, which were approved based on PFS data and have not as yet shown an OS benefit.”

Title: Clinical Trial in Progress: Pivotal Study of VB-111 Combined with Paclitaxel vs. Paclitaxel for Treatment of Platinum-Resistant Ovarian Cancer (OVAL, VB-111-701/GOG-3018)
Authors: Arend, R.C., et al.
Session: Gynecologic Cancer
Session type: Poster Session
Abstract: 5599

About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal registration enabling clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.

About VB-111 (ofranergene obadenovec)
VB-111 is an investigational anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that is designed to use a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).

About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications. VBL Therapeutics has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL Therapeutics’s lead oncology product candidate, ofranergene obadenovec (VB-111), is an investigational, first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is currently being studied in a VBL Therapeutics-sponsored Phase 3 potential registration trial for platinum-resistant ovarian cancer.

[MF82]

Looks like same numbers as last review, good to hear!

[MF82]

I agree on the data, but the change in enthusiasm brings back bad memories...I hope we get a more positive review in Q3.

[Oren1976]

Yes but here we have data that vb111 is doing great 69% response rate in the first 60 patients when fever and at least 58% when non fever is almost too good to be true

[MF82]

Oren, doesn’t this Dsmc PR sound just like the one they released in the fall of 2017 for rgbm? Maybe that is partially the reason for the drop...

[MF82]

Biggest volume I’ve seen on this stock and it is in the red...disappointing

[Oren1976]

$VBLT the word unanimously is missing in this dsmc decision . In previous reports VBL said the decision was made unanimously. It means this time they voted and the majority won minority . There is more chance the minority voted to stop trial due to success than the option they voted to stop trial due to failure. The reason there is more chance is actually 2 reasons. 1. The decision itself by majority to continue means vb-111 isn't failing. 2. The fact the first 60 patients had 10% or more advantage and the fact 55% response rate continued in 200 patients. My conclusion therefore- there were votes in the dsmc that thought the trial should be stopped due to success

[Oren1976]

In recent presentation at Wainwright convention CEO said they can lead to 70% of patients to react with fever but they reach only 40% by killing the fever using corticosteroids and other fever killer drugs. This company keep making crucial mistakes that destroy their effective anti cancer drug. Right before he mentioned this fact he said we have 70% response rate in patients that react with fever. Moreover ,if you look at the data of the failed GLOBE phase 3 trial in gbm you will notice that febrile patients lived longer than control arm. If the people from VBL could induce fever in 70% of patients in GLOBE TRIAL we may have had a successful trial also in GBM

[Ihub58]

I too have been following this company for quite a while now
For sure I am down more than a few $’s
Like you, I hope they turn the corner with Ovarian and MOSPD2

[Oren1976]

1 more year to buy the stock at price of $1 ? I still gamble on their success and keep buying . All the past users here and in other forum left this loser stock but I believe in long term investments especially in biotech. It can take 20 years before you make money out of these companies. Thank God i have patience of even 100 years in stock market. I plan to make a fortune from this company. I predict huge success here in the ovarian cancer phase 3 trial. 2021 is the year to become rich here

[whytestocks]

Breaking News: $VBLT VBL Therapeutics to Present at the Chardan 4th Annual Genetic Medicines Conference

TEL AVIV, Israel, Sept. 29, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced Prof. Dror Harats, M.D., Chief Executive Officer,...

Find out more VBLT - VBL Therapeutics to Present at the Chardan 4th Annual Genetic Medicines Conference

[ClayTrader]

* * $VBLT Video Chart 09-11-2020 * *

Link to Video - click here to watch the technical chart video

[Ihub58]

No pump here
The news this morning from VBL was VERY GOOD !
Added more

[Golden Cross]

$VBLT VBL Therapeutics Presents MOSPD2 Bi-Specific Antibody Activity and Potential Survival Benefit for Solid Tumors in Late Breaking Research Session of the AACR Virtual Annual Meeting

[Oren1976]

It's old news just presentation . The good news hopefully q3 in second interim. Good luck

[Ihub58]

Great news released this morning
We are going a lot higher here folks!

[Oren1976]

They mentioned 69% responders in febrile patients so it's obvious most of the complete responders if not all of them are in treatment arm.